FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acro...
Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Biocompatibility Assessme...
FDA publishes a draft guidance with recommendations for the placement and content of drug interaction information in labeling for human drugs and biol...
Sangamo Therapeutics reaches an agreement with FDA on a clear regulatory pathway to accelerated approval for the companys gene therapy candidate ST-92...
FDA names CDRH deputy director Michelle Tarver as the new Center director, replacing retiring head Jeff Shuren, who hand-picked his replacement.
FDA says a new open-access dataset on gait patterns in patients with Parkinsons disease may lead to novel medical devices.
Three stakeholders tell FDA they oppose the idea of the agency developing product-specific guidances to promote biosimilar development.
FDA posts an executive summary and questions for discussion at a scheduled 11/20-21 meeting of its Digital Health Advisory Committee to discuss total ...
